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The Medical Imaging & Technology Alliance is calling on the FDA to establish a framework that distinguishes between servicing and remanufacturing activities for medical imaging devices. Read More
Australia’s Therapeutic Goods Administration reached the end of its three-year transition period to the 2016 version of ISO 13485 and devicemakers using the updated standard to show Quality Management System (QMS) conformity are now expected to have their systems up-to-date. Read More
The FDA issued a proposed rule aimed at modernizing mammography quality standards and better positioning the agency to act when violations are found. Read More
Two breast implant manufacturers were served with warning letters after the FDA found they failed to comply with post-approval study requirements. Read More
The FDA is considering a total product lifecycle monitoring approach to emerging artificial intelligence devices, the agency said in a proposed rulemaking issued April 2. Read More
The FDA issued a new draft guidance laying out how the agency is updating uniform inspections—other than for-cause inspections—to reflect the FDA Reauthorization Act of 2017. Read More